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临床试验/NCT01578434
NCT01578434已完成4 期

Role of Calcium And Vitamin D In Nutritional Rickets And It's Management

Lady Hardinge Medical College0 个研究点目标入组 67 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
67
主要终点
Healing of rickets

研究概览

简要总结

Rickets, a common nutritional disorder, is usually considered to be due to vitamin D deficiency. However, in the last few decades many studies have shown that in tropical countries, with abundance of sunshine, calcium deficiency may play a more important role in the causation of rickets. Studies from adults in India have also shown that calcium intake of our population is much below the recommended allowance. The calcium deficiency gets compounded by the high level of phytates in the conventional vegetarian diet consumed by the majority of the population. There are few studies on children in India / other Asian countries on assessment of dietary calcium intake.

However, recent studies from many nations of the world have also shown a wide spread prevalence of vitamin D deficiency in adolescent and adult population. A study done at our own hospital has shown a high prevalence of vitamin D deficiency in lactating mothers and their infants.

Since both Calcium and Vitamin D deficiency are likely to be present in children, it is not clear what plays a more important role in the etiology of rickets in India or other Asian countries.

The present study is therefore planned with the following objectives:

  1. To study the dietary calcium intake, sun exposure and serum vitamin D levels in children with and without rickets.
  2. To compare the role of Calcium Carbonate, Vitamin D and a combination of the two in the treatment of nutritional rickets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 6 months to 5 years with rickets

排除标准

  • Non nutritional cause of rickets
  • taken vitamin D or calcium supplements in last 6 months
  • children presenting with convulsions

研究组 & 干预措施

Calcium Carbonate

Active Comparator

Calcium: 75 mg/kg calcium daily for 3 months

干预措施: Calcium Carbonate (Drug)

Vitamin D

Active Comparator

Vitamin D: 6 lakh IU single im dose

干预措施: Vitamin D (Drug)

Vitamin D and Calcium

Active Comparator

vitamin D and Calcium: combination of above two

干预措施: Vitamin D and Calcium (Drug)

结局指标

主要结局

Healing of rickets

时间窗: 6 months

Assessment of healing of rickets on biochemical and radiological assessment

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Varun

Principal Investigator, Senior Resident Physician

Lady Hardinge Medical College

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